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510(k) K811679

SILASTIC TENDON PASSER H.P. by Dow Corning Corp. Healthcare Industries Materials — Product Code HWQ

K811679 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "SILASTIC TENDON PASSER H.P.". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
  • K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
  • K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 1985)
  • K843995 — TF-II HIP PROSTHESIS (April 23, 1985)
  • K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
  • K840357 — SSA HIP PROSTHESIS (February 17, 1984)
  • K831479 — METAL-BACKED ACETABULAR CUP (June 15, 1983)
  • K812864 — SILASTIC VOICE PROSTHESIS (November 24, 1981)
  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K801175 — SILASTIC II MAMMARY IMPLANT (December 18, 1980)

Other clearances for product code HWQ

  • K970360 — MITEK SUTURE RETROGRADER (March 10, 1997)
  • K923381 — SOFT TISSUE EXPANDER (May 5, 1993)
  • K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE (May 5, 1993)
  • K885311 — MENISCUS MENDER II LOOP (February 9, 1989)
  • K843592 — VICO MICRO SURGICAL INSTRUMENTS (October 5, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K841622 — SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K791960 — ROTH-KENNEDY PASSER (October 4, 1979)

FDA data resources