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FDA 510(k)

FIBER OPTICS SIGMOIDOSCOPE

K-Number: K771919 · 1977-10-20

ApplicantPropper Mfg. Co., Inc.
Decision Date1977-10-20
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIBER OPTICS SIGMOIDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Propper Mfg. Co., Inc.. It received FDA 510(k) clearance on 1977-10-20 under 510(k) number K771919. The device is classified under product code GCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER OPTICS SIGMOIDOSCOPE?

FIBER OPTICS SIGMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 1977-10-20. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K771919.

When did FIBER OPTICS SIGMOIDOSCOPE receive FDA 510(k) clearance?

FIBER OPTICS SIGMOIDOSCOPE received FDA 510(k) clearance on 1977-10-20, under 510(k) number K771919.

Who is the listed applicant for FIBER OPTICS SIGMOIDOSCOPE?

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

What is the FDA product code for FIBER OPTICS SIGMOIDOSCOPE?

The FDA product code for FIBER OPTICS SIGMOIDOSCOPE is GCP.

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Other records listing Propper Mfg. Co., 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.

K111453STEAM DOT BLU PROCESS INDICATORK102894CLASSIX CHEMICAL STERILIZATION INDICATORK082620ONCE-A-DAY VERTOS TEST PACKK031152PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)K991618BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATORK991276PASS/FAIL CHALLENGE PACK

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Related Devices (Code: GCP)

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.

K954614EOS BRAND DISPOSABLE PROCTOSCOPENorth Eos Industries, Inc.K896505PORGES UNIVERSAL HANDLESPorges Corp.K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.K862424STEERABLE CATHETER SYSTEMEndovationsK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEEndotherapeuticsK843683MODULAR FIBERSCOPE SYSTEMReichert Scientific Instruments

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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