Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4760](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4760) → GDT — Staple, Removable (Skin) # GDT · Staple, Removable (Skin) _General, Plastic Surgery · 21 CFR 878.4760 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT ## Overview - **Product Code:** GDT - **Device Name:** Staple, Removable (Skin) - **Regulation:** [21 CFR 878.4760](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4760) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K963234](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K963234.md) | STAPLE REMOVAL KIT | Continental Medical Laboratories, Inc. | Oct 21, 1996 | SESE | | [K943719](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K943719.md) | VISISTAT STAPLER | Pilling Weck, Inc. | Aug 24, 1994 | SESE | | [K925526](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K925526.md) | MANIPLER DISPOSABLE SKIN STAPLER | Matsutani Seisakusho Co. , Ltd. | Jun 24, 1993 | SESE | | [K915430](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K915430.md) | SKIN STAPLE REMOVER KIT | Cypress Medical Products, Ltd. | Feb 28, 1992 | SEKD | | [K911204](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K911204.md) | QUALTEX SKIN STAPLE EXTRACTOR | Deroyal Industries, Inc. | May 8, 1991 | SESE | | [K910586](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K910586.md) | AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* | United States Surgical, A Division of Tyco Healthc | Mar 7, 1991 | SESE | | [K900486](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K900486.md) | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | Davis & Geck, Inc. | Apr 20, 1990 | SESE | | [K861711](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K861711.md) | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | Busse Hospital Disposables, Inc. | May 16, 1986 | SESE | | [K851974](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K851974.md) | V. MUELLER VITAL SKIN STAPLER | American V. Mueller | Jun 11, 1985 | SESE | | [K844838](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K844838.md) | SKIN STAT II SKIN STAPLING MEDICAL DEVICE | Edward Weck, Inc. | Jan 23, 1985 | SESE | | [K844837](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K844837.md) | VISISTAT SKIN STAPLING DEVICE | Edward Weck, Inc. | Jan 23, 1985 | SESE | | [K833085](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K833085.md) | STAPLE REMOVER SR300P | Prosper, Inc. | Dec 14, 1984 | SESE | | [K833357](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K833357.md) | VYDAX 525-550 & 5100 FLUOROTELOMER | ETHICON, Inc. | Dec 12, 1983 | SESE | | [K832709](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K832709.md) | SKIN STAPLING DEVICE SC2000 | Prosper, Inc. | Sep 26, 1983 | SESE | | [K822365](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K822365.md) | CENTURION SKIN STAPLE REMOVER | Tri-State | Aug 27, 1982 | SESE | | [K821024](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K821024.md) | DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE | Howmedica Corp. | May 14, 1982 | SESE | | [K801444](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K801444.md) | SKIN STAPLE REMOVER #523770 | Edward Weck, Inc. | Jul 14, 1980 | SESE | | [K800535](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K800535.md) | 3M DISPOSABLE SKIN STAPLER | 3M Company | Apr 4, 1980 | SESE | | [K760734](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT/K760734.md) | REGULAR AND WIDE SKIN STAPLES | ETHICON, Inc. | Nov 3, 1976 | SESE | ## Top Applicants - Edward Weck, Inc. — 3 clearances - ETHICON, Inc. — 2 clearances - Prosper, Inc. — 2 clearances - 3M Company — 1 clearance - American V. Mueller — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com