Flexi-Temno Biopsy Needle

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

Full name

Bauer Flexi-Temno Biopsy Needle

510(k) Number

K902320 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Proact 1

  Class II

  FDA 510(k) K003909 Active Cleared 13 Jun 2001

• Quick Core II

  Class II

  FDA 510(k) K941256 Active Cleared 13 Jul 1994

• Proact Biopsy Needle Enchancements

  Class II

  FDA 510(k) K926559 Active Cleared 22 Mar 1993

• Bauer Temno Biopsy Needle

  Class II

  FDA 510(k) K902319 Active Cleared 6 Sep 1990

• Bone-Temno/Sternum-Temno

  Class II

  FDA 510(k) K913306 Active Cleared 1 Nov 1991

• Proact with Gel or Proact 1

  Class II

  FDA 510(k) K052243 Active Cleared 12 Apr 2006

• What is the Flexi-Temno Biopsy Needle used for?

  The Flexi-Temno Biopsy Needle is designed for tissue sampling in diagnostic and therapeutic procedures within gastroenterology and urology. Its flexible design helps facilitate precise tissue acquisition in organs such as the liver, kidney, and prostate, making it suitable for procedures where anatomical flexibility is beneficial.

• Is the Flexi-Temno Biopsy Needle single-use or reusable?

  The Flexi-Temno Biopsy Needle is supplied as a single-use, sterile instrument. This ensures patient safety and reduces the risk of cross-contamination, adhering to standard aseptic techniques required in clinical settings.

• What regulatory clearance does the Flexi-Temno Biopsy Needle have?

  The Flexi-Temno Biopsy Needle has received FDA 510(k) clearance with a decision of substantial equivalence (SESE) granted in 1990. It is classified under FDA device class 2 and regulated under the 510(k) clearance process.

• Are there specific sizes or packaging details available for the Flexi-Temno Biopsy Needle?

  The provided data does not explicitly state the specific sizes or detailed packaging information for the Flexi-Temno Biopsy Needle. However, multiple registration numbers indicate various lot or batch identifiers, which may correspond to different sizes or configurations.

• Can the Flexi-Temno Biopsy Needle be used in MRI environments?

  No MRI safety information is provided for the Flexi-Temno Biopsy Needle. Clinicians should verify compatibility with MRI equipment and protocols before use in MRI environments to ensure patient safety.