DRC · Class II · 21 CFR 870.1390

FDA Product Code DRC: Trocar

Leading manufacturers include Pressure Products Medical Device Manufacturing, LLC, United States Surgical, A Division of Tyco Healthc and Shanghai Microport EP Medtech Co., Ltd..

51
Total
51
Cleared
123d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 178d recently vs 121d historically

FDA 510(k) Cleared Trocar Devices (Product Code DRC)

51 devices
1–24 of 51
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 30d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 93d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 29d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 148d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 144d
Cleared Jun 15, 1989
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707
United States Surgical, A Division of Tyco Healthc
Cardiovascular · 28d
Cleared Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
K781221
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Aug 16, 1977
ADVANSET
K771261
C.R. Bard, Inc.
Cardiovascular · 36d

About Product Code DRC - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code DRC since 1977, with 51 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - DRC Product Code

Recent submissions under DRC have taken an average of 178 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.

DRC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →