Home / 510(k) Clearances / K813187

510(k) K813187

PILLING LACRIMAL INTUBATION SYSTEM by Narco Scientific — Product Code HNL

K813187 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PILLING LACRIMAL INTUBATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 28, 1982. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 28, 1982
Date Received
Nov 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Probe, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type
510(k) Exempt

Other clearances by Narco Scientific

  • K830338 — NARCOTRACE 80 (Dec 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (Oct 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (Oct 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (Sep 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (Sep 12, 1983)
  • K831460 — AS 30/TCP MODULE (Jul 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (Jun 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (Apr 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (Apr 8, 1983)

Other clearances for product code HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (Oct 5, 1984)
  • K840861 — TSE-ANDERSON MODIFIED LACRIMAL GROOV (May 9, 1984)
  • K833671 — STERILE OIL AND GUIDEWIRE (Jan 10, 1984)
  • K831901 — LACIMAL INTUBATION SETS (Jul 12, 1983)
  • K812255 — ETHICON LACRIMAL STENT (Aug 20, 1981)
  • K802845 — CONCEPT CANALICULUS INTUBATION SET (Dec 17, 1980)
  • K801232 — JACKSON LACRIMAL INTUBATION SET (Jun 17, 1980)
  • K800089 — CRAWFORD LACRIMAL INTUBATION SET (Mar 3, 1980)
  • K770194 — NASO-LACRIMAL DUCT INSERT (Feb 14, 1977)

FDA data resources

Source: FDA 510(k) database entry for K813187. Report a data issue: hello@regdatalab.com.