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FDA 510(k)

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300

K-Number: K853291 · 1985-10-10

ApplicantBio-Detek, Inc.
Decision Date1985-10-10
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Detek, Inc.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K853291. 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 GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300?

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K853291.

When did GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 receive FDA 510(k) clearance?

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 received FDA 510(k) clearance on 1985-10-10, under 510(k) number K853291.

Who is the listed applicant for GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300?

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

What is the FDA product code for GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300?

The FDA product code for GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 is HAM.

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Other records listing Bio-Detek, 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.

K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325K071321POCKETCPRK040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORK984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

View all 14 devices →

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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