FDA product code MCZ: Suture Removal Kit
MCZ is the FDA product code for suture removal kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under MCZ, from 13 different applicants. The average 510(k) review took 137 days (median 121). FDA has posted 16 recalls for MCZ devices, 5 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Suture Removal Kit |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCZ clearance
Top MCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Healthcare Supply Co., Inc. | 2 | 1993-03-23 |
| Trinity Laboratories, Inc. | 2 | 1992-05-22 |
| Amsino International, Inc. | 1 | 2005-05-02 |
| Continental Medical Laboratories, Inc. | 1 | 1997-02-14 |
| Grand Medical Products | 1 | 1996-11-27 |
8 more applicants have MCZ clearances. See the full list in Caduvo.
Most recent MCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050656 | Amsino International, Inc. | AMSINO SUTURE REMOVAL KIT | 2005-05-02 | 49 |
| K964827 | Continental Medical Laboratories, Inc. | PROD. NO. 01-132 - SUTURE REMOVAL KIT | 1997-02-14 | 74 |
| K963714 | Grand Medical Products | GRAND MEDICAL SUTURE REMOVAL KIT | 1996-11-27 | 72 |
| K943046 | Sterile Concepts, Inc. | SKIN STAPLE REMOVAL TRAYS | 1994-07-29 | 32 |
| K941465 | Clinical Resources, Inc. | SUTURE REMOVAL KIT | 1994-04-22 | 25 |
Recalls for MCZ devices
16 product recalls in 13 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-12-24.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MCZ?
MCZ is the FDA product code for suture removal kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is MCZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCZ?
Across 15 cleared submissions the average was 137 days from receipt to decision (median 121).
Which companies have the most MCZ clearances?
American Healthcare Supply Co., Inc. (2); Trinity Laboratories, Inc. (2); Amsino International, Inc. (1); Continental Medical Laboratories, Inc. (1); Grand Medical Products (1).
Have MCZ devices been recalled?
Yes: 16 product recalls across 13 recall events; the most recent began 2025-12-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MCZ
- Run a recall and safety report across every MCZ manufacturer
- Watch product code MCZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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