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FDA 510(k)

KODNER ANAL PERIONEAL RETRACTOR

K-Number: K870897 · 1987-06-04

ApplicantSur-Med Instruments, Inc.
Decision Date1987-06-04
Product CodeFFO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KODNER ANAL PERIONEAL RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sur-Med Instruments, Inc.. It received FDA 510(k) clearance on 1987-06-04 under 510(k) number K870897. The device is classified under product code FFO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODNER ANAL PERIONEAL RETRACTOR?

KODNER ANAL PERIONEAL RETRACTOR is a medical device that received FDA 510(k) clearance on 1987-06-04. The listed applicant is Sur-Med Instruments, Inc.. The 510(k) number is K870897.

When did KODNER ANAL PERIONEAL RETRACTOR receive FDA 510(k) clearance?

KODNER ANAL PERIONEAL RETRACTOR received FDA 510(k) clearance on 1987-06-04, under 510(k) number K870897.

Who is the listed applicant for KODNER ANAL PERIONEAL RETRACTOR?

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

What is the FDA product code for KODNER ANAL PERIONEAL RETRACTOR?

The FDA product code for KODNER ANAL PERIONEAL RETRACTOR is FFO.

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Other records listing Sur-Med Instruments, 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.

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Related Devices (Code: FFO)

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.

K993544SPACE-OR RETRACTORAdvanced Surgical Concepts (Asc)K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.K853119URODYN 1000Dantec Electronics, Inc.K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.

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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