Drape, Transurethral Resection (TUR)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K760175 ↗

FDA Product Code

EYX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Telescope, Rigid Endoscope

  Class II

  FDA 510(k) K760177 Active Cleared 30 Aug 1976

• Bougie, Filiform, Jackson

  Class I

  FDA 510(k) K770959 Active Cleared 14 Jun 1977

• Pfister-Schwartz Stone Retriever

  Class II

  FDA 510(k) K771302 Active Cleared 2 Aug 1977

• Scissor - 1.5mm Probe Point, Angled

  Class I

  FDA 510(k) K760792 Active Cleared 11 Nov 1976

• Teflon Coated Resectoscope Sheath

  Class II

  FDA 510(k) K761242 Active Cleared 16 Dec 1976

• Converse Altar Retractor

  Class I

  FDA 510(k) K760851 Active Cleared 10 Mar 1977

See all devices from V. Mueller O.V. Baxter Healthcare Corp. →

• What is the DRAPE, TRANSURETHRAL RESECTION (TUR) used for?

  This drape is used during transurethral resection (TUR) procedures to protect the surgical site and allow repeated finger insertion, providing a barrier between the surgeon's finger and the operative field in general and plastic surgery settings.

• Is the DRAPE, TRANSURETHRAL RESECTION (TUR) sterile or non-sterile when supplied?

  The device is supplied non-sterile, as indicated in the specifications, and is intended for single use only, meaning it should not be reprocessed or reused after a procedure.

• What materials and components make up the DRAPE, TRANSURETHRAL RESECTION (TUR)?

  The drape consists of a pure latex sheet with an integrated self-retaining finger cot, designed to remain in place on the finger during TUR procedures to facilitate repeated insertion while maintaining a protective barrier.

• What is the regulatory classification and clearance pathway for the DRAPE, TRANSURETHRAL RESECTION (TUR)?

  The device is classified as a Class II medical device under product code EYX and regulation number 878.4370, and it received FDA 510(k) clearance K760175 on August 30, 1976, based on substantial equivalence to a predicate device.