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FDA 510(k)

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

K-Number: K914329 · 1992-04-02

ApplicantEllman Intl. Mfg., Inc.
Decision Date1992-04-02
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl. Mfg., Inc.. It received FDA 510(k) clearance on 1992-04-02 under 510(k) number K914329. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION?

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Ellman Intl. Mfg., Inc.. The 510(k) number is K914329.

When did SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION receive FDA 510(k) clearance?

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION received FDA 510(k) clearance on 1992-04-02, under 510(k) number K914329.

Who is the listed applicant for SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION?

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

What is the FDA product code for SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION?

The FDA product code for SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION is HGI.

Related Clinical Trials

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.

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Other records listing Ellman Intl. Mfg., 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.

K911461SURGITRON

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, 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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