Panels › Gastroenterology, Urology › Product code FCL · Class 1
Forceps, Biopsy, Non-Electric
Regulation 876.1075
0510(k)s in 12 months (39 all time)
3recalls in 12 months (11 all time)
2recalls that name a 510(k)
Top companies in FCL
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 6 |
| Richard Wolf GmbH | 0 | 4 |
| C.R. Bard, Inc. | 3 | 0 |
| Cox Medical Ent., Inc. | 3 | 0 |
| Symbiosis Corp. | 3 | 0 |
| Esco Precision, Inc. | 2 | 0 |
| Mill-Rose Laboratory | 2 | 0 |
| Portlyn Corp. | 2 | 0 |
| Spectrascience, Inc. | 2 | 0 |
| American Endoscopy, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Boston Scientific Corporation Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:
Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360. Open, Classified |
FCL | None listed |
| Jul 31, 2026 | Boston Scientific Corporation Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:
1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320.
2. Radial Jaw 4 LC 240cm Open, Classified |
FCL | None listed |
| Jul 31, 2026 | Boston Scientific Corporation Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:
1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400.
2. Radial Jaw 4 SC 240c Open, Classified |
FCL | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Open, Classified |
FCL | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Open, Classified |
FCL | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Open, Classified |
FCL | K971315 |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Open, Classified |
FCL | K971315 |
| Aug 22, 2016 | Cook Inc. Transluminal Biliary Biopsy Forceps Set
Forceps, Biopsy, Non-Electric
Intended for access to and biopsy of tissue within the biliary ductal system Terminated |
FCL | None listed |
| Jun 4, 2010 | Boston Scientific Corporation Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
UPN/Catalog Number: MOO513330
The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is package Terminated |
FCL | None listed |
| Jun 4, 2010 | Boston Scientific Corporation Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Box 80, 240cm
UPN/Catalog Number: M00513334 Terminated |
FCL | None listed |
| Jun 4, 2010 | Boston Scientific Corporation Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Inner Pouch 240cm, Box 20
UPN/Catalog Number: M00513331 Terminated |
FCL | None listed |
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