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510(k) K771625

LEININGEO AORTIC PUNCH #310-395 & 397 by J. Jamner Surgical Instruments, Inc. — Product Code DWS

K771625 is an FDA 510(k) premarket notification submitted by J. Jamner Surgical Instruments, Inc. for the device "LEININGEO AORTIC PUNCH #310-395 & 397". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. J. Jamner Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
August 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by J. Jamner Surgical Instruments, Inc.

  • K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS (November 21, 2008)
  • K944670 — JARIT RECOMMENDED SINUS INSTRUMENTS (February 2, 1995)
  • K944870 — JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 (November 2, 1994)
  • K941565 — JARIT RECOMMENDED SINUS INSTRUMENTS (May 16, 1994)
  • K932456 — JARIT SURGICAL INSTRUMENTS (April 21, 1994)
  • K933728 — JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, (February 23, 1994)
  • K931928 — JARIT SURGICAL INSTRUMENTS (November 10, 1993)
  • K931959 — JARIT SURGICAL INSTRUMENTS (October 5, 1993)
  • K931878 — JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 (August 19, 1993)
  • K771624 — COPE LUNG FORCEPS #305-218 (September 6, 1977)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources