Sigmoidoscope And Accessories, Flexible/rigid
Gastroenterology, Urology · 21 CFR 876.1500
to examine and perform procedures within the sigmoid (descending) colon
Recent MDR events
54 adverse event reports on file
- PENTAXMar 16, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-50598
- KIT SIGMOIDOSCOPE LIGHTED SGL USE STRLMar 9, 2026MalfunctionBiosealMW5184910
- PENTAXJan 7, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-50041
- PENTAXFeb 27, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-51102
- PENTAXJan 28, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-50517
- PENTAXJan 16, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-50249
- PENTAXDec 26, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-59297
- PENTAXDec 13, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-59004
- PENTAXOct 28, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-57838
- PENTAXOct 15, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-57467
Event type breakdown
Recalls
2 recall events for this product code
- Pentax Medical CompanyTerminatedJul 23, 2016
Signmoidoscope
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Z-2280-2016 · View FDA record ↗ - Pentax Medical CompanyTerminatedJun 28, 2016
Signmoidoscope
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Z-2075-2016 · View FDA record ↗
Registered firms
39 firms currently registered for this product code
Deroyal Industries, Inc.
POWELL, TN, US
Honer Medizin-technik Gmbh & Co. Kg
SPAICHINGEN Baden-Wurttemberg, DE
Imperial Trading Limited
Bridgetown Saint Michael, BB
Pentax Medical (penang) Sdn. Bhd.
Penang Pulau Pinang, MY
Worldwide Supplies Limited
Hong Kong, HK
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Fujifilm Healthcare Manufacturing Corporation Sano Office
Sano City Tochigi, JP
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Video Endoscopy Estonia Oue
Laagri Harjumaa, EE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Veenak International Limited
BIRMINGHAM, GB
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Cbr Enterprise Limited
Hong Kong, HK
510(k) clearances
24 clearances for this product code
- Akos Biomedical, Inc.Jun 27, 1997
K964131 · ENDOSCOPE
- Welch Allyn, Inc.Apr 17, 1997
K970382 · VS-100 VIDEO SIGMOIDOSCOPE
- Vision-Sciences, Inc.Jan 3, 1997
K964326 · VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
- Vision-Sciences, Inc.Dec 16, 1996
K964100 · VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
- Vision-Sciences, Inc.Nov 21, 1996
K963344 · DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
- Pentax Precision Instrument Corp.Jun 24, 1996
K961567 · ES-3840, VIDEO SIGMOIDOSCOPE
- Pentax Precision Instrument Corp.Mar 21, 1996
K951577 · ES-3800, VIDEO SIGMOIDOSCOPE
- Welch Allyn, Inc.Aug 1, 1995
K950429 · VIDEO SIGMOIDOSCOPE