ETHICON DRILL BIT AND DRILL GUIDE
FDA 510(k) clearance K944590 · decided 1995-05-11
Clearance details
- K-number
- K944590
- Device name
- ETHICON DRILL BIT AND DRILL GUIDE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-19
- Decision date
- 1995-05-11
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- HSZ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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| SODEM HIGH SPEED SYSTEM (K954080) | Sodem Diffusion SA | 1995-10-16 |
| SPINALPLANE (K934336) | Synvasive Technology, Inc. | 1995-03-10 |
| FILTER, DIFFUSER (K940276) | Anspach Mfg., Inc. | 1994-11-16 |
| PNEUMATIC WIRE TENSIONER (K942760) | Smith & Nephew Richards, Inc. | 1994-09-06 |
| ARTHREX CIRCULAR HARVESTING SAW (K941681) | Arthrex, Inc. | 1994-08-25 |
| TAVA WIRE-DRIVER (K935367) | Tava Surgical Instruments | 1994-04-21 |
| PNEUMATIC WIRE TENSIONER (K934431) | Smith & Nephew Richards, Inc. | 1994-01-27 |
| THE DE SOUTTER M182 DRILL (K930785) | De Soutter Medical, Ltd. | 1993-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |