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510(k) K810937

ANIS IRRIGATING SPATULA by American V. Mueller — Product Code HND

K810937 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "ANIS IRRIGATING SPATULA". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code HND (Spatula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)

Other clearances for product code HND

  • K863990 — THORNTON TITANIUM SILVER SPATULA (October 31, 1986)
  • K801609 — MADDOX LENS SPATULA CAT. #7245 (August 13, 1980)
  • K801608 — MCCULLEY CONTINUOUS SUTURE TIGHTNER (August 12, 1980)
  • K791983 — SPATULA'S #'S 7618,7248,7240,7242,5108 (October 4, 1979)
  • K761253 — CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM (December 16, 1976)

FDA data resources