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FDA 510(k)

ENDOMETRIAL SAMPLER

K-Number: K901896 · 1990-08-13

ApplicantKirwan Surgical Products, Inc.
Decision Date1990-08-13
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOMETRIAL SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Kirwan Surgical Products, Inc.. It received FDA 510(k) clearance on 1990-08-13 under 510(k) number K901896. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMETRIAL SAMPLER?

ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 1990-08-13. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K901896.

When did ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 1990-08-13, under 510(k) number K901896.

Who is the listed applicant for ENDOMETRIAL SAMPLER?

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

What is the FDA product code for ENDOMETRIAL SAMPLER?

The FDA product code for ENDOMETRIAL SAMPLER is EJF.

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Other records listing Kirwan Surgical Products, 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.

K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDEK070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSK062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESK052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

View all 18 devices →

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, 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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