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510(k) K990910

MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS by Mtp Medical Technical Promotion GmbH — Product Code HIH

K990910 is an FDA 510(k) premarket notification submitted by Mtp Medical Technical Promotion GmbH for the device "MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS". The FDA issued a decision of Substantially Equivalent on June 3, 1999. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Mtp Medical Technical Promotion GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1999
Date Received
March 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Mtp Medical Technical Promotion GmbH

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K021811 — UNIDRIVE II PLUS DISPOSABLE TUBING SET (June 19, 2002)
  • K020599 — MTP CLEARVISION DISPOSABLE TUBING SET (March 13, 2002)
  • K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET (July 19, 2001)
  • K000337 — MTP DISPOSABLE TROCAR VALVES (April 12, 2000)
  • K994066 — MTP DISPOSABLE TROCARS (January 20, 2000)
  • K990909 — MTP UROPUMP DISPOSABLE TUBING SET (June 9, 1999)
  • K990912 — MTP EXTRACTION BAG (June 9, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (June 3, 1999)

Other clearances for product code HIH

  • K253020 — Strauss Surgical Resection Instruments (June 4, 2026)
  • K254050 — Manual Tissue Removal Device (May 15, 2026)
  • K254251 — InnovexView (GC146-17, GC150-20, GC155-23) (February 26, 2026)
  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)

FDA data resources