GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
FDA 510(k) clearance K935070 · decided 1994-01-25
Clearance details
- K-number
- K935070
- Device name
- GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-25
- Decision date
- 1994-01-25
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- FCL
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (K032092) | Olympus Optical Co., Ltd. | 2003-07-16 |
| SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (K973611) | Spectrascience, Inc. | 1997-12-02 |
| AUXILIARY INSTRUMENTS FOR URS (K971315) | Richard Wolf Medical Instruments Corp. | 1997-09-15 |
| INJECTO FLUSH (K964120) | Robert J. Jynch, Jr. | 1996-12-30 |
| SPECTRA SCIENCE BIOPSY FORCEPS (K963517) | Spectrascience, Inc. | 1996-12-02 |
| OLYMPUS FB SERIES BIOPSY FORCEPS (K955065) | Olympus America, Inc. | 1996-01-24 |
| FORCEPS, BIOPSY, NON-ELECTRIC (K952863) | Annex Medical, Inc. | 1995-07-19 |
| DYNABITE UROLOGICAL FORCEPS (K952391) | Portlyn Corp. | 1995-06-01 |
| RITE-BITE BIOPSY FORCEPS (K951048) | Mill-Rose Laboratory | 1995-03-15 |
| MODULAR BIOPSY FORCEP (K946360) | Cox Medical Ent., Inc. | 1995-03-06 |
| DIENER RETRIEVAL DEVICES (K950559) | Mill-Rose Laboratory | 1995-02-16 |
| SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (K946238) | Symbiosis Corp. | 1995-01-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |