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FDA 510(k)

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

K-Number: K974036 · 1997-12-22

ApplicantThe Prometheus Group
Decision Date1997-12-22
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is The Prometheus Group. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974036. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE?

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is The Prometheus Group. The 510(k) number is K974036.

When did PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE receive FDA 510(k) clearance?

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974036.

Who is the listed applicant for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE?

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

What is the FDA product code for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE?

The FDA product code for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE is HIR.

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Other records listing The Prometheus Group 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.

K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundK030039PATHWAY STM-10 PELVIC FLOOR STIMULATORK023906PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEMK001515PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000K993976PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSORK973537PATHWAY ELECTROMYOGRAPH

View all 11 devices →

Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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