Skin Staple Removal Trays
FDA 510(k) K943046 · Sterile Concepts, Inc.
510(k) numberK943046
Submission
- Device name
- Skin Staple Removal Trays
- Applicant
- Sterile Concepts, Inc.
Richmond, VA, US - Received
- June 27, 1994
- Decision date
- July 29, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K915827 | A.C.S. Suture Removal KitMCZ · Traditional | American Carolina Stamping | 12/08/1992SESK |
More from American Carolina Stamping
| 510(k) | Device | Decision |
|---|---|---|
| K951231 | Orthopedic PacksGAN · Traditional | 12/01/1995SE |
| K951081 | OB/GYN PacksKNA · Traditional | 11/13/1995SE |
| K952539 | Radiology PacksLRO · Traditional | 07/14/1995SE |
| K951478 | General and Plastic Surgery PacksLRO · Traditional | 06/13/1995SE |
| K944139 | Dental Hygiene TrayLYY · Traditional | 12/15/1994SE |
| K943047 | IV Start KitsKMK · Traditional | 09/14/1994SE |
| K943090 | Suture Removal TraysFRG · Traditional | 08/22/1994SEKD |
| K940864 | Dentist with Assistant PackEIA · Traditional | 08/02/1994SE |
| K920763 | Lacerattion TrayKDD · Traditional | 09/28/1992SESK |
Questions and answers
When was Skin Staple Removal Trays cleared by the FDA?
Skin Staple Removal Trays (K943046) received a 510(k) decision of Unknown on July 29, 1994, 32 days after the submission was received.
What is the product code of K943046?
The FDA product code is MCZ – Suture Removal Kit, a Class I (low risk) device regulated under 21 CFR 878.4800.