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FDA 510(k)

B100 DISPOSABLE HANDPIECE

K-Number: K894762 · 1989-09-15

ApplicantBeacon Laboratories, Inc.
Decision Date1989-09-15
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

B100 DISPOSABLE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K894762. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B100 DISPOSABLE HANDPIECE?

B100 DISPOSABLE HANDPIECE is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Beacon Laboratories, Inc.. The 510(k) number is K894762.

When did B100 DISPOSABLE HANDPIECE receive FDA 510(k) clearance?

B100 DISPOSABLE HANDPIECE received FDA 510(k) clearance on 1989-09-15, under 510(k) number K894762.

Who is the listed applicant for B100 DISPOSABLE HANDPIECE?

The FDA 510(k) record lists Beacon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B100 DISPOSABLE HANDPIECE?

The FDA product code for B100 DISPOSABLE HANDPIECE is HAM.

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Other records listing Beacon Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K930243FLEXIBLE EXTENDERK930497ARGON HANDPIECESK925708DISPOSABLE ELECTROSURGERY BALL ELECTRODEK922289SESQUIPOLAR(TM) MIS ELECTRODEK925619DISPOSABLE HAND-SWITCHING ESU PENCILK915788MIS ELECTROSURGICAL ELECTRODES

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Related Devices (Code: HAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.K945861BERGEN 710 ESUBergen Mfg.K913300LAPAROSTAT(TM)Cook Ob/GynK920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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