VYDAX 525-550 & 5100 FLUOROTELOMER
FDA 510(k) clearance K833357 · decided 1983-12-12
Clearance details
- K-number
- K833357
- Device name
- VYDAX 525-550 & 5100 FLUOROTELOMER
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-28
- Decision date
- 1983-12-12
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GDT
- Device class
- 1
- Regulation number
- 878.4760
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| STAPLE REMOVAL KIT (K963234) | Continental Medical Laboratories, Inc. | 1996-10-21 |
| VISISTAT STAPLER (K943719) | Pilling Weck, Inc. | 1994-08-24 |
| MANIPLER DISPOSABLE SKIN STAPLER (K925526) | Matsutani Seisakusho Co. , Ltd. | 1993-06-24 |
| SKIN STAPLE REMOVER KIT (K915430) | Cypress Medical Products, Ltd. | 1992-02-28 |
| QUALTEX SKIN STAPLE EXTRACTOR (K911204) | Deroyal Industries, Inc. | 1991-05-08 |
| AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (K910586) | United States Surgical, A Division of Tyco Healthc | 1991-03-07 |
| APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER (K900486) | Davis & Geck, Inc. | 1990-04-20 |
| SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE (K861711) | Busse Hospital Disposables, Inc. | 1986-05-16 |
| V. MUELLER VITAL SKIN STAPLER (K851974) | American V. Mueller | 1985-06-11 |
| SKIN STAT II SKIN STAPLING MEDICAL DEVICE (K844838) | Edward Weck, Inc. | 1985-01-23 |
| VISISTAT SKIN STAPLING DEVICE (K844837) | Edward Weck, Inc. | 1985-01-23 |
| STAPLE REMOVER SR300P (K833085) | Prosper, Inc. | 1984-12-14 |
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 |