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FDA 510(k)

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE

K-Number: K925333 · 1994-09-27

ApplicantAspen Labs
Decision Date1994-09-27
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Labs. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K925333. 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 SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE?

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Aspen Labs. The 510(k) number is K925333.

When did SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE receive FDA 510(k) clearance?

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE received FDA 510(k) clearance on 1994-09-27, under 510(k) number K925333.

Who is the listed applicant for SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE?

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

What is the FDA product code for SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE?

The FDA product code for SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE is HGI.

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Other records listing Aspen Labs 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.

K970493HYFRECATOR 2000K931215HAND-TROL SK912046SINGLE USE LEE ELECTRODEK905654ELECTROSURGICAL UNIT WITH ACCESSORIESK904240SINGLE USE LAPARSCOPIC ELECTRODE

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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