Ballard MIC-KEY G Low Profile Gastrostomy Replacement Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K993138 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Safety Shield Suction Catheter

  Class I

  FDA 510(k) K873810 Active Cleared 11 Dec 1987

• Safety Shield Kit

  Class II

  FDA 510(k) K873731 Active Cleared 15 Jan 1988

• Reusable Bronchial Biopsy Forceps

  Class II

  FDA 510(k) K022398 Active Cleared 11 Oct 2002

• Trach Care Start Kit

  Class I

  FDA 510(k) K873732 Active Cleared 13 Oct 1987

• Trach Care Catheter

  Class I

  FDA 510(k) K872621 Active Cleared 15 Sep 1987

• 72 Hour Use Trach Care with Microban

  Class II

  FDA 510(k) K974630 Active Cleared 11 Mar 1998

See all devices from Ballard Medical Products →

• What is the purpose of the MIC-KEY G Low Profile Gastrostomy Replacement Kit?

  The Ballard MIC-KEY G Low Profile Gastrostomy Replacement Kit is designed for patients requiring enteral support or decompression via a gastrostomy. Its low-profile design stays flush with the skin, reducing interference with clothing and lowering the chance of accidental pulling or dislodgement.

• What components are included in the MIC-KEY G Replacement Kit?

  The kit includes a medical grade silicone tube with a tapered distal tip, silicone internal retention balloon, and a proximal anti-reflux valve. It also comes with a SECUR-LOK extension set connector mechanism and features a radiopaque stripe for visibility.

• Is the MIC-KEY G Replacement Kit sterile and how is it supplied?

  Yes, the replacement kit is gamma sterilized and supplied ready for use. It is available in various sizes to accommodate different patient needs, and the radiopaque stripe allows for visibility under imaging.

• What is the regulatory status of the MIC-KEY G Low Profile Gastrostomy Replacement Kit?

  The device has received FDA 510(k) clearance with a decision code of SESE, indicating it is substantially equivalent to predicate devices. It was cleared on October 20, 1999, and is classified under product code KNT.