APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
FDA 510(k) clearance K900486 · decided 1990-04-20
Clearance details
- K-number
- K900486
- Device name
- APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
- Applicant
- Davis & Geck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-01
- Decision date
- 1990-04-20
- Days to decision
- 78 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
- Danbury, CT, 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 |
| 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 |
| VYDAX 525-550 & 5100 FLUOROTELOMER (K833357) | ETHICON, Inc. | 1983-12-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008) | Davis & Geck, Inc. | 1996-11-15 |
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(TM) (P840041/S005) | Davis & Geck, Inc. | 1994-04-20 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006) | Davis & Geck, Inc. | 1992-03-24 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005) | Davis & Geck, Inc. | 1991-10-17 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004) | Davis & Geck, Inc. | 1991-03-29 |
| NOVAFIL(TM) (P840041/S003) | Davis & Geck, Inc. | 1990-07-06 |