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FDA 510(k)

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

K-Number: K100517 · 2010-04-29

ApplicantInstrumed International, Inc.
Decision Date2010-04-29
Product CodeHDA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed International, Inc.. It received FDA 510(k) clearance on 2010-04-29 under 510(k) number K100517. The device is classified under product code HDA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX?

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX is a medical device that received FDA 510(k) clearance on 2010-04-29. The listed applicant is Instrumed International, Inc.. The 510(k) number is K100517.

When did INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX receive FDA 510(k) clearance?

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX received FDA 510(k) clearance on 2010-04-29, under 510(k) number K100517.

Who is the listed applicant for INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX?

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

What is the FDA product code for INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX?

The FDA product code for INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX is HDA.

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Other records listing Instrumed International, 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.

K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALK092544INSTRUMED VASCULAR CLAMPSK081651INSTRUMED RONGEURK071771INSTRUMED RETRACTORSK040855INSTRUMED LAPAROSCOPE AND ACCESSORIES

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Related Devices (Code: HDA)

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.

K092827DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XXDimeda Instrumente GmbHK013747TEKNO-MEDICAL OBSTETRICAL FORCEPSTekno Medical Optik-Chirurgie GmbH & Co.K951529V. MUELLER OBSTETRICAL (OB) FORCEPSBaxter Healthcare CorpK914552CMI VACUUM PUMPColumbia Medical & Surgical, Inc.K905583ILC FORCEPS PADSInman Liebelt Corp.K903205AUTO SUTURE(R) ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc

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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