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FDA 510(k)

HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO

K-Number: K911341 · 1991-06-24

ApplicantUltracision, Inc.
Decision Date1991-06-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO is the device name listed in this FDA 510(k) record. The listed applicant is Ultracision, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911341. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO?

HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Ultracision, Inc.. The 510(k) number is K911341.

When did HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO receive FDA 510(k) clearance?

HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911341.

Who is the listed applicant for HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO?

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

What is the FDA product code for HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO?

The FDA product code for HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO is GEI.

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Other records listing Ultracision, 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.

K952726ULTRACISION HARMONIC SCAPELK941897ULTRACISON HARMONIC SCALPEL HS2 BLADEK930352HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.K924917HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORYK925699HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.K924281HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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