Home / 510(k) Clearances / K871315

510(k) K871315

ORAL ASPIRATOR by Endovations — Product Code DYN

K871315 is an FDA 510(k) premarket notification submitted by Endovations for the device "ORAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on April 15, 1987. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Endovations has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1987
Date Received
April 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Saliva Ejector
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Endovations

  • K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER (February 8, 1996)
  • K942110 — INJECT-SNARE (October 13, 1994)
  • K944049 — OXYGEN MOUTHGUARD (October 11, 1994)
  • K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME (February 28, 1994)
  • K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH (October 8, 1991)
  • K913870 — 5MM MICROSCISSORS (September 16, 1991)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K892218 — ENDO-SPONGE (May 31, 1989)
  • K883093 — TRANSENDOSCOPIC ASPIRATION NEEDLE (December 8, 1988)
  • K873360 — ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG (March 30, 1988)

Other clearances for product code DYN

  • K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (August 17, 1994)
  • K935758 — HYGOFLEX SALIVA-EJECTOR (March 21, 1994)
  • K935616 — SALIVA EJECTOR DISPOSABLE (March 21, 1994)
  • K924211 — EJECTOR (March 31, 1993)
  • K920492 — HIGH VAC (May 11, 1992)
  • K921117 — MINIDAM (May 5, 1992)
  • K900631 — SALIVA ABSORBER - DENTAL (April 4, 1990)
  • K870599 — TIP, DENTAL SUCTION APPARATUS (March 23, 1987)
  • K864300 — SILIVA EJECTOR/ORAL CAVITY EVACUATOR (November 24, 1986)
  • K863768 — SALIVA EJECTORS (October 27, 1986)

FDA data resources