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FDA 510(k)

ANAL/RECTAL SYRINGE

K-Number: K761229 · 1977-02-24

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1977-02-24
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANAL/RECTAL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Ace Orthopedic Manufacturing Co.. It received FDA 510(k) clearance on 1977-02-24 under 510(k) number K761229. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAL/RECTAL SYRINGE?

ANAL/RECTAL SYRINGE is a medical device that received FDA 510(k) clearance on 1977-02-24. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K761229.

When did ANAL/RECTAL SYRINGE receive FDA 510(k) clearance?

ANAL/RECTAL SYRINGE received FDA 510(k) clearance on 1977-02-24, under 510(k) number K761229.

Who is the listed applicant for ANAL/RECTAL SYRINGE?

The FDA 510(k) record lists Ace Orthopedic Manufacturing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANAL/RECTAL SYRINGE?

The FDA product code for ANAL/RECTAL SYRINGE is KOA.

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Other records listing Ace Orthopedic Manufacturing Co. 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.

K934643ACE HUMERAL NAILK934962AIM SUPRACONDYLAR NAILK936045ACE UNILATERAL FIXATOR IIK926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREWK920738ACE 100 DEGREES TUBULAR PLATEK813554ACE/KYLE CAPTURED HIP SCREW

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Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American 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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