LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH— 510(k) K872884

Clearance details

Applicant

Look, Inc.

Product code

Code HMX

Device class

Class 1

Regulation

21 CFR 886.4350

Advisory panel

Ophthalmic

Date received

1987-07-22

Decision date

1987-08-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boston, MA, US

• K010305 — WEISS RETINAL CANNULA2001-05-02
• K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES2000-05-09
• K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1997-05-20
• K943932 — STERISEAL OPHTHALMIC CANNULA1995-01-18
• K942403 — INFUSION CANNULA1994-08-17

• K943949 — POLYVIOLENE SURGICL SUTURE1994-11-10
• K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE1993-12-23
• K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES1993-12-22
• K926167 — POLYVIOLENE SUTURE-REVISED LABELING1993-12-17
• K926168 — SILK SUTURES-REVISED LABELING1993-12-17

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →