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FDA 510(k)

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION

K-Number: K922154 · 1994-04-21

ApplicantOlsen Electrosurgical, Inc.
Decision Date1994-04-21
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Electrosurgical, Inc.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K922154. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION?

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Olsen Electrosurgical, Inc.. The 510(k) number is K922154.

When did INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION receive FDA 510(k) clearance?

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION received FDA 510(k) clearance on 1994-04-21, under 510(k) number K922154.

Who is the listed applicant for INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION?

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

What is the FDA product code for INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION?

The FDA product code for INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION is HIB.

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Other records listing Olsen Electrosurgical, 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.

K912611OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USEK913108TEFLON COATED ELECTRODES/ELECTRODES HANDLESK912612SMOKE/ODOR EVACUATOR #757K885200600 & 900 SERIES ELECTRODES & 755 & 756 HANDLEK885199#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHESK884171#875 DISPOSABLE BIOPOLAR CABLE

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Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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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