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FDA 510(k)

O'BRIEN GONIOMETER

K-Number: K926237 · 1993-08-02

ApplicantSgarlato Laboratories, Inc.
Decision Date1993-08-02
Product CodeKQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

O'BRIEN GONIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Sgarlato Laboratories, Inc.. It received FDA 510(k) clearance on 1993-08-02 under 510(k) number K926237. The device is classified under product code KQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O'BRIEN GONIOMETER?

O'BRIEN GONIOMETER is a medical device that received FDA 510(k) clearance on 1993-08-02. The listed applicant is Sgarlato Laboratories, Inc.. The 510(k) number is K926237.

When did O'BRIEN GONIOMETER receive FDA 510(k) clearance?

O'BRIEN GONIOMETER received FDA 510(k) clearance on 1993-08-02, under 510(k) number K926237.

Who is the listed applicant for O'BRIEN GONIOMETER?

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

What is the FDA product code for O'BRIEN GONIOMETER?

The FDA product code for O'BRIEN GONIOMETER is KQW.

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Other records listing Sgarlato Laboratories, 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.

K043204SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMPK990101PAIN CONTROL INFUSION PUMPK982931THREADED FIXATION PINK926262FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICEK922292LUNDEEN SUBTALAR PEG IMPLANTK905795SGARLATO FLEXIBLE HINGE TOE IMPLANT

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Related Devices (Code: KQW)

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.

K901744DOBBHOFF(R) RETRIEVAL FORCEPSBiosearch Medical Products, Inc.K870767THE (CROM) TESTERTwin City Surgical, Inc.K850082HAND HELD GONIOMETERChattanooga Group, Inc.K831550FINGER BONIOMETER BK7506Fred Sammons, Inc.K812778THE TELOS EQUIPMENTThe Telos Co.K810441UNIVERSAL GONIMETERFred Sammons, 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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