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510(k) K882673

SIGMA 1 WOBBLER BIOPSY KIT by Kontron Instruments, Inc. — Product Code FCH

K882673 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "SIGMA 1 WOBBLER BIOPSY KIT". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code FCH (Tray, Biopsy, Without Biopsy Instruments), a Class I device regulated under 21 CFR 876.4730. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
June 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Biopsy, Without Biopsy Instruments
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Kontron Instruments, Inc.

  • K971038 — KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (September 24, 1997)
  • K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS (December 15, 1993)
  • K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (September 27, 1993)
  • K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION (March 8, 1993)
  • K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (June 19, 1991)
  • K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (January 15, 1991)
  • K896437 — KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (December 3, 1990)
  • K892222 — 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (September 14, 1990)
  • K882955 — SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (January 26, 1990)
  • K896386 — MINIMON 7133B PATIENT MONITOR (December 13, 1989)

Other clearances for product code FCH

  • K852105 — MANAN UBK ULTRASONIC GUIDED BIOPSY KIT (June 18, 1985)

FDA data resources