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FDA 510(k)

LEEP REDIKIT

K-Number: K910253 · 1991-04-18

ApplicantCooperSurgical, Inc.
Decision Date1991-04-18
Product CodeHEE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEEP REDIKIT is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K910253. The device is classified under product code HEE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEEP REDIKIT?

LEEP REDIKIT is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K910253.

When did LEEP REDIKIT receive FDA 510(k) clearance?

LEEP REDIKIT received FDA 510(k) clearance on 1991-04-18, under 510(k) number K910253.

Who is the listed applicant for LEEP REDIKIT?

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

What is the FDA product code for LEEP REDIKIT?

The FDA product code for LEEP REDIKIT is HEE.

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Other records listing CooperSurgical, 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: HEE)

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.

K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGERocket Medical PlcK021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEAvid Medical, Inc.K983897CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.K980238GYNEX EXTENDED REACH NEEDLEGynex Corp.K973671ENDOCERVICAL BLOCK NEEDLEA & A 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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