A.C.S. Suture Removal Kit
FDA 510(k) K915827 · American Carolina Stamping
510(k) numberK915827
Submission
- Device name
- A.C.S. Suture Removal Kit
- Applicant
- American Carolina Stamping
Etowah, NC, US - Received
- December 30, 1991
- Decision date
- December 8, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MCZ – Suture Removal Kit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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…
Other 510(k)s with product code MCZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050656 | Amsino Suture Removal KitMCZ · Traditional | Amsino International, Inc. | 05/02/2005SE |
| K964827 | Prod. No. 01-132 - Suture Removal KitMCZ · Traditional | Continental Medical Laboratories, Inc. | 02/14/1997SE |
| K963714 | Grand Medical Suture Removal KitMCZ · Traditional | Grand Medical Products | 11/27/1996SE |
| K943046 | Skin Staple Removal TraysMCZ · Traditional | Sterile Concepts, Inc. | 07/29/1994SESK |
| K941465 | Suture Removal KitMCZ · Traditional | Clinical Resources, Inc. | 04/22/1994SE |
| K931597 | Carapace Incision and Drainage TraysMCZ · Traditional | Carapace, Inc. | 11/05/1993SEKD |
| K925015 | Sterile Suture Removal KitMCZ · Traditional | Customed, Inc. | 06/07/1993SESK |
| K924835 | Valu-Pak Sterile Suture Removal Kit (AHC-50-549560MCZ · Traditional | American Healthcare Supply Co., Inc. | 03/23/1993SESK |
| K924834 | Premiere Sterile Suture Removal KIT(HC-50-54957)MCZ · Traditional | American Healthcare Supply Co., Inc. | 03/23/1993SEKD |
| K922339 | Suture Removal KitMCZ · Traditional | Transidyne General Corp. | 12/11/1992SESK |
Questions and answers
When was A.C.S. Suture Removal Kit cleared by the FDA?
A.C.S. Suture Removal Kit (K915827) received a 510(k) decision of Unknown on December 8, 1992, 344 days after the submission was received.
What is the product code of K915827?
The FDA product code is MCZ – Suture Removal Kit, a Class I (low risk) device regulated under 21 CFR 878.4800.