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FDA 510(k)

ENDOCERVICAL BLOCK NEEDLE

K-Number: K021224 · 2002-07-12

ApplicantWallach Surgical Devices, Inc.
Decision Date2002-07-12
Product CodeHEE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOCERVICAL BLOCK NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021224. 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 ENDOCERVICAL BLOCK NEEDLE?

ENDOCERVICAL BLOCK NEEDLE is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K021224.

When did ENDOCERVICAL BLOCK NEEDLE receive FDA 510(k) clearance?

ENDOCERVICAL BLOCK NEEDLE received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021224.

Who is the listed applicant for ENDOCERVICAL BLOCK NEEDLE?

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

What is the FDA product code for ENDOCERVICAL BLOCK NEEDLE?

The FDA product code for ENDOCERVICAL BLOCK NEEDLE is HEE.

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Other records listing Wallach Surgical Devices, 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.

K020711WALLACH LOOP ELECTRODEK000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORK992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)K984306`THE INSEMINATOR' (PROPOSED)

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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 PlcK000117AVID-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.K954718ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGEEllman Intl., 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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