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FDA 510(k)

WSP CODE 4310 STRESSCATH

K-Number: K850694 · 1985-05-17

ApplicantWarne Surgical Products, Ltd.
Decision Date1985-05-17
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WSP CODE 4310 STRESSCATH is the device name listed in this FDA 510(k) record. The listed applicant is Warne Surgical Products, Ltd.. It received FDA 510(k) clearance on 1985-05-17 under 510(k) number K850694. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WSP CODE 4310 STRESSCATH?

WSP CODE 4310 STRESSCATH is a medical device that received FDA 510(k) clearance on 1985-05-17. The listed applicant is Warne Surgical Products, Ltd.. The 510(k) number is K850694.

When did WSP CODE 4310 STRESSCATH receive FDA 510(k) clearance?

WSP CODE 4310 STRESSCATH received FDA 510(k) clearance on 1985-05-17, under 510(k) number K850694.

Who is the listed applicant for WSP CODE 4310 STRESSCATH?

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

What is the FDA product code for WSP CODE 4310 STRESSCATH?

The FDA product code for WSP CODE 4310 STRESSCATH is FAP.

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 Warne Surgical Products, Ltd. 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.

K850696WSP CODE 4300 DIOMASTER DIAGNOSTICK850695WSP CODE 4301 DIOMASTER THERAPEUTICK850693WSP CODE 4315 PADTESTK841511HAEMATURIA CATHETERSK840687KIDNEY TRANSPLANT CATHETERK841411ROLLED NECK W/PLUG

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech 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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