MCZ — Suture Removal Kit Class I
FDA product code MCZ covers "Suture Removal Kit", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MCZ
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050656 | amsino international | AMSINO SUTURE REMOVAL KIT | May 2, 2005 |
| K964827 | continental medical laboratories | PROD. NO. 01-132 - SUTURE REMOVAL KIT | February 14, 1997 |
| K963714 | grand medical products | GRAND MEDICAL SUTURE REMOVAL KIT | November 27, 1996 |
| K943046 | sterile concepts | SKIN STAPLE REMOVAL TRAYS | July 29, 1994 |
| K941465 | clinical resources | SUTURE REMOVAL KIT | April 22, 1994 |
| K931597 | carapace | CARAPACE INCISION AND DRAINAGE TRAYS | November 5, 1993 |
| K925015 | customed | STERILE SUTURE REMOVAL KIT | June 7, 1993 |
| K924835 | american healthcare supply co | VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 | March 23, 1993 |
| K924834 | american healthcare supply co | PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) | March 23, 1993 |
| K922339 | transidyne general | SUTURE REMOVAL KIT | December 11, 1992 |
| K915827 | american carolina stamping | A.C.S. SUTURE REMOVAL KIT | December 8, 1992 |
| K920283 | trinity laboratories | DISPOSABLE SKIN STAPLE REMOVER | May 22, 1992 |
| K920280 | trinity laboratories | SUTURE REMOVAL KIT, STERILE, DISPOSABLE | May 11, 1992 |
| K910361 | megadyne medical products | SUTURE REMOVAL KIT | March 27, 1991 |
| K812132 | e.m. adams | STERILE SUTURE REMOVAL KIT | December 1, 1981 |