SUTURE REMOVAL KIT
FDA 510(k) clearance K910361 · decided 1991-03-27
Clearance details
- K-number
- K910361
- Device name
- SUTURE REMOVAL KIT
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-29
- Decision date
- 1991-03-27
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MCZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hauppauge, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Megadyne Medical Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMSINO SUTURE REMOVAL KIT (K050656) | Amsino International, Inc. | 2005-05-02 |
| PROD. NO. 01-132 - SUTURE REMOVAL KIT (K964827) | Continental Medical Laboratories, Inc. | 1997-02-14 |
| GRAND MEDICAL SUTURE REMOVAL KIT (K963714) | Grand Medical Products | 1996-11-27 |
| SKIN STAPLE REMOVAL TRAYS (K943046) | Sterile Concepts, Inc. | 1994-07-29 |
| SUTURE REMOVAL KIT (K941465) | Clinical Resources, Inc. | 1994-04-22 |
| CARAPACE INCISION AND DRAINAGE TRAYS (K931597) | Carapace, Inc. | 1993-11-05 |
| STERILE SUTURE REMOVAL KIT (K925015) | Customed, Inc. | 1993-06-07 |
| PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) (K924834) | American Healthcare Supply Co., Inc. | 1993-03-23 |
| VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 (K924835) | American Healthcare Supply Co., Inc. | 1993-03-23 |
| SUTURE REMOVAL KIT (K922339) | Transidyne General Corp. | 1992-12-11 |
| A.C.S. SUTURE REMOVAL KIT (K915827) | American Carolina Stamping | 1992-12-08 |
| DISPOSABLE SKIN STAPLE REMOVER (K920283) | Trinity Laboratories, Inc. | 1992-05-22 |
Recalls involving this device
No recalls on record reference this clearance.