FDA 510(k)

HAND-TROL S

K-Number: K931215 · 1994-03-28

Decision Date1994-03-28

Product CodeDWG

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HAND-TROL S is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Labs. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K931215. The device is classified under product code DWG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAND-TROL S?

HAND-TROL S is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Aspen Labs. The 510(k) number is K931215.

When did HAND-TROL S receive FDA 510(k) clearance?

HAND-TROL S received FDA 510(k) clearance on 1994-03-28, under 510(k) number K931215.

Who is the listed applicant for HAND-TROL S?

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 HAND-TROL S?

The FDA product code for HAND-TROL S is DWG.

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 2000 K925333SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE K912046SINGLE USE LEE ELECTRODE K905654ELECTROSURGICAL UNIT WITH ACCESSORIES K904240SINGLE USE LAPARSCOPIC ELECTRODE

Related Devices (Code: DWG)

K942823MAHE INSTRUMENTSMahe Intl., Inc.K932345TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USEConmedcorp K925708DISPOSABLE ELECTROSURGERY BALL ELECTRODEBeacon Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.