KARL STORZ DRILL
FDA 510(k) clearance K952008 · decided 1995-07-26
Clearance details
- K-number
- K952008
- Device name
- KARL STORZ DRILL
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-28
- Decision date
- 1995-07-26
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GEY
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Culver City, CA, 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 |
|---|---|---|
| ADVANCED TURBO DRIVE SYSTEM (K050519) | Linvatec Corp. | 2005-05-17 |
| ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020621) | Arthrocare Corp. | 2002-03-28 |
| SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738) | Depuyacromed | 2001-11-14 |
| MEDNEXT 1000 DRILL (K972308) | Mednext, Inc. | 1997-08-20 |
| AQUA SPRAY (K971941) | Boyd Industries, Inc. | 1997-08-14 |
| BONE AND MARROW COLLECTION SYSTEM KIT (K971782) | Biomedical Ent., Inc. | 1997-07-29 |
| BONE & MARROW CLLECTION SYSTEM (K971268) | Biomedical International Corp. | 1997-07-03 |
| ORTHOCHUCK (K964252) | Buckman Co., Inc. | 1997-05-27 |
| ANSPACH LUBRICATING SYSTEM II (K970530) | The Anspach Effort, Inc. | 1997-05-05 |
| BME BONE DRILL BITS (K964073) | Biomedical Ent., Inc. | 1996-11-14 |
| SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789) | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| BONE & MARROW COLLECTION SYSTEM (K961901) | Biomedical Ent., Inc. | 1996-08-06 |
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 |