Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → HAM — Apparatus, Electrosurgical # HAM · Apparatus, Electrosurgical _General, Plastic Surgery · 21 CFR 878.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM ## Overview - **Product Code:** HAM - **Device Name:** Apparatus, Electrosurgical - **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **3rd-party reviewable:** yes ## Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K153472](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K153472.md) | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | Jun 23, 2016 | SESE | | [K000079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K000079.md) | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | Nikomed U.S.A., Inc. | Feb 4, 2000 | SESE | | [K993306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K993306.md) | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | Paladin Medical, Inc. | Nov 3, 1999 | SESE | | [K945861](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K945861.md) | BERGEN 710 ESU | Bergen Mfg. | Mar 1, 1995 | SESE | | [K913300](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K913300.md) | LAPAROSTAT(TM) | Cook Ob/Gyn | Apr 2, 1992 | SESE | | [K920100](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K920100.md) | GSU HANDPIECE ADAPTER | Beacon Laboratories, Inc. | Feb 3, 1992 | SESE | | [K911353](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K911353.md) | EMC MODEL NO. STATOME 900 | Emc Industries | Jun 24, 1991 | SESE | | [K901248](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K901248.md) | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | Apr 3, 1990 | SESE | | [K881334](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K881334.md) | LIGHT COAGULATOR LC 250 | Nk-Optik GmbH | Nov 16, 1989 | SESE | | [K895337](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K895337.md) | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | Sep 15, 1989 | SESE | | [K894762](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K894762.md) | B100 DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | Sep 15, 1989 | SESE | | [K894663](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K894663.md) | BEAMER ONE | Beacon Laboratories, Inc. | Sep 15, 1989 | SESE | | [K884175](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K884175.md) | #820/821 BIPOLAR FORCEPS | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE | | [K884174](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K884174.md) | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE | | [K884173](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K884173.md) | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE | | [K884172](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K884172.md) | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE | | [K884171](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K884171.md) | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE | | [K871435](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K871435.md) | BARD EMS SYSTEM 6000 E.S.U. | C.R. Bard, Inc. | May 11, 1987 | SESE | | [K863091](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K863091.md) | BICORD BY QMED | Qmed, Inc. | Aug 29, 1986 | SESE | | [K853291](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K853291.md) | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | Bio-Detek, Inc. | Oct 10, 1985 | SESE | ## Top Applicants - Olsen Electrosurgical, Inc. — 5 clearances - Beacon Laboratories, Inc. — 4 clearances - Medical Products Development, Inc. — 2 clearances - Edward Weck, Inc. — 2 clearances - Trident Surgical Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM) **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. 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