P.R.G. Percutaneous Replacement Gastrostomy

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

510(k) Number

K900884 ↗

FDA Product Code

KGC

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESD Substantially Equivalent — Deferred

• Gastrointestinal Tubes & Accessories

  Class II

  FDA 510(k) K945618 Active Cleared 12 Oct 1995

• Background Suction Matt

  Class I

  FDA 510(k) K895727 Active Cleared 24 Oct 1989

• Vessel Occluder

  Class I

  FDA 510(k) K895726 Active Cleared 24 Oct 1989

• Stoma Measuring Device

  Class II

  FDA 510(k) K923692 Active Cleared 7 May 1993

• One Step Button(Tm)

  Class II

  FDA 510(k) K910584 Active Cleared 23 May 1991

• Vessel Loops

  Class I

  FDA 510(k) K895682 Active Cleared 24 Oct 1989

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• What is the P.R.G. Percutaneous Replacement Gastrostomy used for?

  The P.R.G. Percutaneous Replacement Gastrostomy is designed for percutaneous replacement of gastrostomy tubes, allowing clinicians to replace existing gastrostomy access percutaneously without surgical intervention, as indicated in its device description and classification under gastroenterology and urology specialties.

• How is the P.R.G. Percutaneous Replacement Gastrostomy supplied and is it sterile?

  The device data does not specify supply format, sterility, or single-use versus reusable status; therefore, no details about packaging, sterilization method, or reuse limitations can be derived from the provided information.

• What sizes or models are available for the P.R.G. Percutaneous Replacement Gastrostomy?

  The provided device data does not include any specifications regarding sizes, models, dimensions, or reference numbers beyond the device name and K900884 clearance number, so no size or model variations can be confirmed from this source.

• What regulatory pathway was used for the P.R.G. Percutaneous Replacement Gastrostomy?

  The P.R.G. Percutaneous Replacement Gastrostomy received FDA 510(k) clearance under K900884 on July 2, 1990, following a traditional submission on February 26, 1990, and was found substantially equivalent (SESD) to a predicate device, as stated in the authorizations and decision details.