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510(k) K971036

ODONTIT AUTOGENOUS BONE COLLECTION DEVICE by Interpore Intl. — Product Code GCY

K971036 is an FDA 510(k) premarket notification submitted by Interpore Intl. for the device "ODONTIT AUTOGENOUS BONE COLLECTION DEVICE". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Interpore Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
March 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Interpore Intl.

  • K981253 — ULTRACON ULTRAFILTRATOR (December 11, 1998)
  • K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5R (September 25, 1998)
  • K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (October 30, 1997)
  • K960945 — IMZ MEMBRANE TACK SYSTEM (May 24, 1996)
  • K960371 — INTERPORE THREADED IMPLANT (March 8, 1996)
  • K955492 — INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (January 30, 1996)
  • K952167 — IMZ BONE TACK SYSTEM (November 21, 1995)
  • K950165 — INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 100 (March 28, 1995)
  • K922872 — INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (July 25, 1994)
  • K922732 — INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER (February 10, 1994)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)

FDA data resources