Product code MIC— Ear, Nose, Throat

FDA has cleared 8 devices under product code MIC between 1992 and 2002, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 20001 clearance
• 19982 clearances
• 19971 clearance
• 19961 clearance
• 19941 clearance
• 19921 clearance

• Seare Biomedical Corp.2 clearances
• Spectrum Designs, Inc.1 clearance
• Rand Scientific Corp.1 clearance
• Pillar Surgical, Inc.1 clearance
• Hanson Medical, Inc.1 clearance
• Applied Biomaterial Technologies1 clearance
• Aesthetic and Reconstructive Technologies, Inc.1 clearance

• K021337 — AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.·2002-07-03
• K002633 — SILMAX PECTORAL IMPLANTPillar Surgical, Inc.·2000-11-21
• K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.·1998-09-30
• K983043 — SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.·1998-09-30
• K973729 — POWERFLEX PEC IMPLANTHanson Medical, Inc.·1997-12-24
• K961072 — PEC IMPLANTRand Scientific Corp.·1996-04-19
• K944163 — SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, Inc.·1994-11-07
• K913768 — PEC IMPLANTApplied Biomaterial Technologies·1992-02-03