510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Asensus Surgical, Inc.

Morrisville, NC, US

Asensus Surgical, Inc. appears in FDA device records in Morrisville, NC. FDA records list 21 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
5
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Asensus Surgical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Transenterix, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 21 510(k) clearances for Asensus Surgical, Inc. between 2009 and 2026. The busiest year on record is 2018, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Asensus Surgical, Inc., by decision year
YearClearances
20092
20101
20111
20122
20171
20183
20193
20201
20213
20221
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254192Senhance Ultrasonic SystemNAYSubstantially Equivalent
K233866Senhance Surgical SystemNAYSubstantially Equivalent
K223095Senhance Surgical SystemNAYSubstantially Equivalent
K220889Senhance Surgical SystemNAYSubstantially Equivalent
K212054Senhance Surgical SystemNAYSubstantially Equivalent
K211325Senhance Surgical SystemNAYSubstantially Equivalent
K202166Senhance Surgical SystemNAYSubstantially Equivalent
K200049Senhance Surgical SystemNAYSubstantially Equivalent
K192877Senhance Surgical SystemNAYSubstantially Equivalent
K191482Senhance Surgical SystemNAYSubstantially Equivalent
K182421Senhance Ultrasonic SystemNAYSubstantially Equivalent
K183098Senhance Surgical SystemNAYSubstantially Equivalent
K181517Senhance Surgical SystemNAYSubstantially Equivalent
K180163TransEnterix Senhance Surgical SystemNAYSubstantially Equivalent
K171120Senhance Surgical Robotic SystemNAYSubstantially Equivalent
K122299SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLARGCJSubstantially Equivalent
K120403SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSERGCJSubstantially Equivalent
K102839SPIDER STANDARD AND ADVANCEDGCJSubstantially Equivalent
K102646SPIDER FLEX MONOPOLAR HOOKGCJSubstantially Equivalent
K091697SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015GCJSubstantially Equivalent
K090902SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003GCJSubstantially Equivalent

Registered establishments

FDA registered establishments for Asensus Surgical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30075939443007593944Asensus Surgical, Inc.1001 Airport Blvd, Suite 110, Morrisville, NC 27560 US2026
30395231303039523130Asensus Surgical, Inc.1001 Hill Dr Ste 155, Durham, NC 27703 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0170-2024Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical systemAsensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.Class ITerminated
Z-2137-2012SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization.Some clip applier units may be inadequate to achieve clip closure.Class IITerminated
Z-1910-2011SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.Terminated
Z-1909-2011SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.Terminated
Z-2465-2010Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NCThe hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain