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FDA 510(k)

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)

K-Number: K862364 · 1986-08-19

ApplicantSwemed Laboratories, Inc.
Decision Date1986-08-19
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent for Some Indications

Device Summary

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) is the device name listed in this FDA 510(k) record. The listed applicant is Swemed Laboratories, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862364. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)?

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Swemed Laboratories, Inc.. The 510(k) number is K862364.

When did NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) receive FDA 510(k) clearance?

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862364.

Who is the listed applicant for NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)?

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

What is the FDA product code for NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)?

The FDA product code for NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) is HEM.

Related Clinical Trials

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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Other records listing Swemed Laboratories, 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.

K862365NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE

Related Devices (Code: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical SystemsK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, 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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