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510(k) K844690

ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT by Jayco Pharmaceuticals — Product Code FCL

K844690 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
December 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Jayco Pharmaceuticals

  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

Other clearances for product code FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (December 2, 1997)
  • K971315 — AUXILIARY INSTRUMENTS FOR URS (September 15, 1997)
  • K964120 — INJECTO FLUSH (December 30, 1996)
  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)
  • K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS (January 24, 1996)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)

FDA data resources