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510(k) K865075

H-H SUBGALEAL TROCAR by Holter-Hausner Intl. — Product Code GYK

K865075 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H SUBGALEAL TROCAR". The FDA issued a decision of Substantially Equivalent on January 13, 1987. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
December 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
Review Panel
NE
Submission Type

Other clearances by Holter-Hausner Intl.

  • K875287 — H-H FLUSHING RESERVOIR (July 14, 1988)
  • K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (January 19, 1988)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K871351 — H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (May 14, 1987)
  • K870660 — H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (May 1, 1987)
  • K853437 — H-H HUNTER TENDON ROD (October 16, 1985)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (October 11, 1996)
  • K934391 — V/P AND L/P CATHETER PASSERS (November 19, 1993)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K932273 — CORDIS TUNNELER (August 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (October 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (September 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (September 18, 1985)
  • K853368 — H-H SHUNT INTRODUCER (September 6, 1985)
  • K841553 — H-H SHUNT PASSERS (May 14, 1984)

FDA data resources