NONClass I

Forceps, Biopsy, Non-electric, Reprocessed

Gastroenterology, Urology · 21 CFR 876.1075

same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

MDR events47All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances3All time

Recent MDR events

47 adverse event reports on file

Event type breakdown

Malfunction40

Unspecified3

Injury3

Other1

Most-reported manufacturers

Sterilmed, Inc.40 Conmed Corporation3 Unspecified1 Cook Endoscopy1 Karl Storz Endoscopy - America, Inc.1 Teleflex Medical1

Recalls

1 recall events for this product code

Sterilmed Inc
TerminatedJan 13, 2009
Biopsy Forceps, Cold
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0575-2009 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

3 clearances for this product code